Research Department of Primary Care and Population Health, University College London, London, UK.
Centre for Research in Public Health and Community Care, University of Hertfordshire, Hatfield, UK.
Lancet. 2023 Nov;402 Suppl 1:S42. doi: 10.1016/S0140-6736(23)02071-8.
NHS frailty services commonly target more severely frail older people, despite evidence suggesting frailty can be prevented or reversed when addressed at an earlier stage. HomeHealth is a new home-based, manualised voluntary sector service supporting older people with mild frailty to maintain their independence through behaviour change. Over six appointments, a trained HomeHealth worker discusses what matters to the older person and supports them to set and achieve goals around mobility, nutrition, socialising and/or psychological wellbeing. The service showed promising effects in a feasibility trial. We aimed to test the clinical and cost-effectiveness of HomeHealth for maintaining independence in older people with mild frailty compared with treatment as usual.
In this single-blind multicentre randomised controlled trial, we recruited community-dwelling older people aged 65 years or older with mild frailty from 27 general practices, community groups and sheltered housing in London, Yorkshire, and Hertfordshire. Participants were randomly assigned (1:1) to receive either HomeHealth monthly for 6 months or treatment as usual (usual GP and outpatient care, no specific frailty services). Our primary outcome was independence in activities of daily living, measured by blinded outcome assessors using the modified Barthel Index, and analysed using linear mixed models, including 6-month and 12-month data and controlling for baseline Barthel score and site. The study was approved by the Social Care Research Ethics Committee, and all participants provided written or orally recorded informed consent. This study is registered with the ISRCTN registry, ISRCTN54268283.
This trial took place between Jan 18, 2021, and July 4, 2023. We recruited 388 participants (mean age 81·4 years; 64% female [n=250], 94% White British/European [n=364], 2·5% Asian [n=10], 1·5% Black [n=6], 2·0% other [n=8]). We achieved high retention for 6-month follow-up (89%, 345/388), 12-month follow-up (86%, 334/388), and medical notes data (89%, 347/388). 182 (93%) of 195 participants in the intervention group completed the intervention, attending a mean of 5·6 appointments. HomeHealth had no effect on Barthel Index scores at 12 months (mean difference 0·250, 95% CI -0·932 to 1·432). At 6 months, there was a small reduction in psychological distress (-1·237, -2·127 to -0·348) and frailty (-0·124, -0·232 to -0·017), and at 12 months, we found small positive effects on wellbeing (1·449, 0·124 to 2·775) in those receiving HomeHealth. Other outcomes in analysis to date showed no significant difference. Health economic outcomes (including quality of life, capability, health services use and care needs or burden) are pending.
This high-quality trial showed that HomeHealth did not maintain independence in older people with mild frailty, and had limited effects upon secondary outcomes. Future studies need to explore different ways to promote health in this population.
National Institute for Health and Care Research Health Technology Assessment (NIHR HTA).
NHS 衰弱服务通常针对更为严重的衰弱老年人，尽管有证据表明，在早期阶段解决衰弱问题时，可以预防或逆转衰弱。 HomeHealth 是一项新的基于家庭的、标准化的志愿部门服务，旨在通过行为改变支持轻度虚弱的老年人保持独立。在六次预约中，经过培训的 HomeHealth 工作人员会讨论对老年人重要的事情，并支持他们设定和实现与行动能力、营养、社交和/或心理健康相关的目标。该服务在一项可行性试验中显示出了有希望的效果。我们旨在测试 HomeHealth 在维持轻度虚弱的老年人独立性方面的临床和成本效益，与常规治疗相比。
在这项单盲多中心随机对照试验中，我们从伦敦、约克郡和赫特福德郡的 27 家全科医生诊所、社区团体和庇护住房招募了年龄在 65 岁及以上、轻度虚弱的社区居住的老年人。参与者被随机分配（1:1）接受每月 6 个月的 HomeHealth 或常规治疗（常规全科医生和门诊护理，没有特定的虚弱服务）。我们的主要结局是使用改良巴氏量表由盲法结局评估者评估的日常生活活动独立性，并使用线性混合模型进行分析，包括 6 个月和 12 个月的数据，并控制基线巴氏量表评分和地点。该研究得到了社会关怀研究伦理委员会的批准，所有参与者均提供了书面或口头记录的知情同意书。这项研究在 ISRCTN 注册中心注册，注册号为 ISRCTN54268283。
该试验于 2021 年 1 月 18 日至 2023 年 7 月 4 日进行。我们招募了 388 名参与者（平均年龄 81.4 岁；64%为女性[250 名]，94%为白种人/欧洲人[364 名]，2.5%为亚洲人[10 名]，1.5%为黑人[6 名]，2.0%为其他种族[8 名]）。我们实现了 6 个月随访（89%，345/388）和 12 个月随访（86%，334/388）的高保留率，以及医疗记录数据（89%，347/388）。干预组的 195 名参与者中有 182 名（93%）完成了干预，平均参加了 5.6 次预约。在 12 个月时，HomeHealth 对巴氏量表评分没有影响（平均差异 0.250，95%CI -0.932 至 1.432）。在 6 个月时，心理困扰（-1.237，-2.127 至 -0.348）和虚弱（-0.124，-0.232 至 -0.017）有所减轻，在 12 个月时，我们发现接受 HomeHealth 的人的幸福感有较小的积极影响（1.449，0.124 至 2.775）。迄今为止，其他分析结果显示没有显著差异。健康经济学结果（包括生活质量、能力、卫生服务使用和护理需求或负担）仍在等待中。
这项高质量的试验表明，HomeHealth 并没有维持轻度虚弱老年人的独立性，并且对次要结局的影响有限。未来的研究需要探索促进这一人群健康的不同方法。
英国国家卫生与保健研究院健康技术评估（NIHR HTA）。
